Medical advisory warnings may have some nasty side effects.
Warning labels meant to protect young people might be doing them more harm than good, according to a Nationwide Children’s Hospital study on antidepressants and youth suicide rates.
The study finds that suicides of Americans under 20 years old rose 18% between 2003 and 2004—the largest single-year increase in more than 15 years. The rate went back down by a slight 5% from 2004 to 2005.
The spike coincides with U.S. Food and Drug Administration’s 2003 and 2004 public warnings that antidepressants might trigger “suicidality”—suicidal thoughts and behaviors, short of actual suicide—in young people age 20 and under who use them, though suicidality usually abated after the first few months of treatment. The FDA first alterted consumers to a possible antidepressant–suicidality link in June 2003 when tests suggested increased risk in young consumers of the antidepressant parotexine.
Over the following 14 months, the FDA sponsored studies of all major antidepressants and held public hearings that discussed findings. It concluded that all brands of antidepressants needed to carry a note of caution; a young patient taking them would be 4% more likely to exhibit suicidality.
In October 2004, the agency ordered drug companies to place “black-box” warnings on the inserts of all their antidepressants. Every warning was to say state the increased risks and urge doctors prescribing antidepressants to watch the patients closely for any changes in behavior: “Anyone considering the use of [drug name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.”
The first warnings appeared in 2005. FDA spokeswoman Sandy Walsh told THE FUTURIST that the warnings were meant to make doctors and patients more cautious.
“The FDA’s intent is to fully inform doctors about the risks and benefits of antidepressants, and not to discourage appropriate prescribing,” says Walsh.
But critics say that doctors and patients became too cautious. Nathan Bridge, Nationwide Children’s Hospital study author, suggests that the warnings might have scared some physicians into not prescribing antidepressants and some young children into not taking them. Bridge worries that the grownups’ concerns backfired, with tragic consequences for some young patients who were denied needed treatments.
“That may mean there are more depressed kids who aren’t being diagnosed and being treated, and that may be more at risk for suicide,” says Bridge.
According to FDA data, a young person suffering from depression is 15% more likely to commit suicide than peers not suffering from depression.
Bridge’s concern is not new. In December 2006, Columbia University psychiatry professor John Mann testified at a public FDA hearing that antidepressant prescriptions to young people declined 22% after the black-box warnings were imposed. He added that the best way to help depressed and suicidal patients is to closely monitor them and prescribe drugs whenever appropriate: “We can do more good by encouraging treatment for all depressed children and adults.”
Child psychiatrist Carolyn Robinowitz told the same committee that the black-box label fueled needless fear about the drugs.
“The imposition of the black box label has resulted in unintended negative consequences restricting access to care and adding to risk,” she said.
She argued further that the warnings fueled negative stereotypes about people with depression, and might even shame some depressed persons from acknowledging their depression and seeking help.
“The black box has contributed to further stigmatization of depression, those who suffer from it, and its treatment,” she says.
Despite the criticisms, the FDA expanded the black-box warning in May 2007 to all patients under 24 years old.
Walsh agrees that excess fear of antidepressants can become a serious problem.
“Findings such as these do raise a concern about the unintended consequences,” she says.
But she defended the black-box warnings as a benefit to doctors and patients alike.
“At this time, nothing indicates a need for change in the boxed warning,” she says, “which urges that particular attention is given to patients starting treatment, still good advice.”—Rick Docksai
Sources: Jeff Bridge, Nationwide Children’s Hospital, Columbus, Ohio. Web site, www.nationwidechildrens.org.
Sandy Walsh, FDA Public Affairs Office. Web site, www.fd.gov.
Psychopharmacologic Drugs Advisory Committee. December 13, 2006. FDA. Web site, www.fda.gov/cder.